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At least 1,189 records · Page 66Linked to original sources
PubMed1990

Further study of the increased mortality following transurethral prostatectomy: a chart-based analysis.

Previous studies using large administrative databases found an elevated relative risk of reoperation and death after transurethral resection of the prostate compared to open prostatectomy. To investigate whether differences in case-mix unmeasured by administrative data explained this finding, we reviewed the charts of 485 patients who had undergone prostatectomy (236 open and 249 transurethral) at the Health Science Centre, Winnipeg, Manitoba, Canada between 1974 and 1980. Data from patient histories, physical examinations and laboratory evaluations were abstracted and used to control for case-mix in models comparing the rates of reoperation and mortality after transurethral versus open prostatectomy. Several models were specified. In all models the relative risk of dying after transurethral prostatectomy remained elevated (1.36 to 1.89), as did the risk for reoperation (3.62). A prospective trial is needed to establish the relative safety and effectiveness of transurethral and open prostatectomy.

Aged↗
PubMed2001

CB6F1-rasH2 mouse: overview of available data.

This article presents data from short-term carcinogenicity studies of compounds tested in the CB6F1-rasH2 transgenic mouse as part of the International Life Sciences Institutes' (ILSI) Health and Environmental Sciences' (HESI) Alternative to Carcinogenicity Testing (ACT) project. Additionally, data from other studies that were not conducted as part of the ILSI program, but used comparable or slightly modified protocols, are included here. A significant number (3 of 4) of the genotoxic carcinogens tested were positive in the rasH2 mouse; the other compound was equivocally positive. The positive control, N-Methyl-N-nitrosurea (MNU), gave reproducible responses across all participating laboratories with tumors noted at multiple sites in the animal. The immunosuppressive human carcinogen. Cyclosporin A, was equivocal. Two hormones that are human tumorigens. Diethylstilbestrol and 17beta-Estradiol, gave positive and negative results, respectively. Of the twelve additional compounds tested that are classified as non-genotoxic rodent carcinogens and putative human non-carcinogens, only the two peroxisome proliferators (clofibrate and diethylhexylphthalate(DEHP)) produced a positive response (liver effects). The three non-genotoxic non-carcinogens that were tested also gave negative responses in the rasH2 model. This result provides confidence that the model is likely to have a low false-positive rate.

Academies and Institutes↗
PubMed2006

An approach for developing a national estimate of waterborne disease due to drinking water and a national estimate model application.

In this paper, the US Environmental Protection Agency (EPA) presents an approach and a national estimate of drinking water related endemic acute gastrointestinal illness (AGI) that uses information from epidemiologic studies. There have been a limited number of epidemiologic studies that have measured waterborne disease occurrence in the United States. For this analysis, we assume that certain unknown incidence of AGI in each public drinking water system is due to drinking water and that a statistical distribution of the different incidence rates for the population served by each system can be estimated to inform a mean national estimate of AGI illness due to drinking water. Data from public water systems suggest that the incidence rate of AGI due to drinking water may vary by several orders of magnitude. In addition, data from epidemiologic studies show AGI incidence due to drinking water ranging from essentially none (or less than the study detection level) to a rate of 0.26 cases per person-year. Considering these two perspectives collectively, and associated uncertainties, EPA has developed an analytical approach and model for generating a national estimate of annual AGI illness due to drinking water. EPA developed a national estimate of waterborne disease to address, in part, the 1996 Safe Drinking Water Act Amendments. The national estimate uses best available science, but also recognizes gaps in the data to support some of the model assumptions and uncertainties in the estimate. Based on the model presented, EPA estimates a mean incidence of AGI attributable to drinking water of 0.06 cases per year (with a 95% credible interval of 0.02-0.12). The mean estimate represents approximately 8.5% of cases of AGI illness due to all causes among the population served by community water systems. The estimated incidence translates to 16.4 million cases/year among the same population. The estimate illustrates the potential usefulness and challenges of the approach, and provides a focus for discussions of data needs and future study designs. Areas of major uncertainty that currently limit the usefulness of the approach are discussed in the context of the estimate analysis.

Communicable Diseases↗
PubMed2006

National Center for Biomedical Ontology: advancing biomedicine through structured organization of scientific knowledge.

The National Center for Biomedical Ontology is a consortium that comprises leading informaticians, biologists, clinicians, and ontologists, funded by the National Institutes of Health (NIH) Roadmap, to develop innovative technology and methods that allow scientists to record, manage, and disseminate biomedical information and knowledge in machine-processable form. The goals of the Center are (1) to help unify the divergent and isolated efforts in ontology development by promoting high quality open-source, standards-based tools to create, manage, and use ontologies, (2) to create new software tools so that scientists can use ontologies to annotate and analyze biomedical data, (3) to provide a national resource for the ongoing evaluation, integration, and evolution of biomedical ontologies and associated tools and theories in the context of driving biomedical projects (DBPs), and (4) to disseminate the tools and resources of the Center and to identify, evaluate, and communicate best practices of ontology development to the biomedical community. Through the research activities within the Center, collaborations with the DBPs, and interactions with the biomedical community, our goal is to help scientists to work more effectively in the e-science paradigm, enhancing experiment design, experiment execution, data analysis, information synthesis, hypothesis generation and testing, and understand human disease.

Biomedical Research↗
PubMed2002

Text-based knowledge discovery: search and mining of life-sciences documents.

Text literature is playing an increasingly important role in biomedical discovery. The challenge is to manage the increasing volume, complexity and specialization of knowledge expressed in this literature. Although information retrieval or text searching is useful, it is not sufficient to find specific facts and relations. Information extraction methods are evolving to extract automatically specific, fine-grained terms corresponding to the names of entities referred to in the text, and the relationships that connect these terms. Information extraction is, in turn, a means to an end, and knowledge discovery methods are evolving for the discovery of still more-complex structures and connections among facts. These methods provide an interpretive context for understanding the meaning of biological data.

Biological Science Disciplines↗
PubMed2006

Role of lenalidomide in the treatment of multiple myeloma and myelodysplastic syndrome.

OBJECTIVE: To evaluate lenalidomide in the treatment of multiple myeloma and myelodysplastic syndrome (MDS). DATA SOURCES: Clinical literature was accessed through MEDLINE (1966-August 2005), Science Citation Index (1980-August 2005), and Proceedings of the American Society of Hematology (2000-2004). DATA SYNTHESIS: New analogs of thalidomide have been synthesized that are more potent and less toxic. Lenalidomide (CC-5013) is currently in Phase III trials for the treatment of multiple myeloma and MDS. Phase II trials demonstrated lenalidomide's efficacy in patients refractory to thalidomide. The full potential of this agent has yet to be proven, but preliminary data seem promising. CONCLUSIONS: Lenalidomide is a potent immunomodulating drug that offers different mechanisms of action and therapeutic potential for the treatment of multiple myeloma, MDS, and other malignancies.

Animals↗
PubMed1999

Fitting the log-F accelerated failure time model with incomplete covariate data.

Data obtained from studies in the health sciences often have incompletely observed covariates as well as censored outcomes. In this paper, we present methods for fitting the log-F accelerated failure time model with incomplete continuous and/or categorical time-independent covariates using the Gibbs sampler. A general location model that allows different covariance structures across cells is specified for the covariates, and ignorable missingness of the covariates is assumed. Techniques that accommodate standard assumptions of ignorable censoring as well as certain types of nonignorable censoring are developed. We compare our approach to traditional complete-case analysis in an application to data obtained from a study of melanoma. The comparison indicates that substantial gains in efficiency are possible with our approach.

Biometry↗
PubMed1994

The role of leukotrienes in inflammation.

OBJECTIVE: To review the biochemistry and biological activities of leukotrienes, focusing on their role in the mediation of inflammatory diseases. DATA SOURCES: MEDLINE (1966-1994), EMBASE (Excerpta Medica; 1974-1994), and other biomedical and drug directory databases (such as Pharmaprojects and IMSworld R&D Focus [1991-1994]) were searched to identify English-language articles (basic science, clinical trial research, and review articles) and abstracts of conference proceedings on leukotrienes and related terms. STUDY SELECTION: Basic science studies on leukotrienes and clinical research studies on the use of leukotriene inhibitors and antagonists in the treatment of inflammatory diseases such as asthma, psoriasis, rheumatoid arthritis, and ulcerative colitis. DATA EXTRACTION: Detailed summaries of data from basic science studies on the formation and actions of leukotrienes and from clinical studies of drugs that block the synthesis or receptor-mediated actions of leukotrienes. DATA SYNTHESIS: Leukotrienes are biologically active 5-lipoxygenase products of arachidonic acid metabolism that are involved in the mediation of various inflammatory disorders. Of these, leukotriene B4 (a potent chemoattractant for leukocytes) and the sulfidopeptide leukotrienes C4, D4, and E4 (which increase vascular permeability and constrict smooth muscle) exert their biological actions through specific ligand-receptor interactions. Selective leukotriene inhibitors and receptor antagonists are currently under evaluation in the treatment of various inflammatory diseases. CONCLUSIONS: Further data on the in vitro and in vivo activities of the leukotriene inhibitors and antagonists should clarify the role of leukotrienes in the pathogenesis of such inflammatory diseases as asthma, rheumatoid arthritis, and inflammatory bowel disease. Leukotriene inhibitors and antagonists will probably become important agents in the group of anti-inflammatory drugs.

Animals↗
PubMed2006

Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines.

Pharmacovigilance science has traditionally been a discipline focussed on the postmarketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has slowly shifted toward earlier, proactive consideration of risks and potential benefits of drugs in the pre- and peri-approval stages of drug development, leading to a maturing of drug safety risk management. Further advances in biology, pharmacology and improvements in computational applications to medicine have led to the development of more complex medicines previously unobtainable and have also permitted a more thorough assessment of risks and potential benefits even earlier in the development process. Elevated public concern with the safety of more sophisticated medicines, combined with new science, have led pharmaceutical innovators, regulators and healthcare professionals to collaborate to develop guidelines, which drive enhanced pharmacovigilance and safety risk management earlier in drug development. In this paper, we review international guidelines on pharmacovigilance planning applicable to the pre-approval phases of medicines development and provide author opinion on these guidelines' potential drug safety implications. We discuss the possible evolution of a pharmaceutical industry model to respond to these guidelines; a view on multidisciplinary safety management teams is provided to encourage refinement of safety-signal identification and risk assessment early in drug development and to communicate important safety concerns to internal research efforts, patients, investigators and regulators. We further describe these functions in the context of the complexities of vulnerable populations, including the example of medicines research for paediatric populations. We also discuss the special role of epidemiology in pre-approval drug development and the impact on epidemiological science of changes to the pharmacovigilance paradigm.

Adverse Drug Reaction Reporting Systems↗
PubMed1997

Clinical forum: a review of intratympanic therapy.

OBJECTIVE: This article provides an overview of the rational basis for the appropriate clinical use of intratympanic aminoglycosides and steroids. DATA SOURCES: The data sources were relevant English language clinical and basic science publications. STUDY SELECTION: The most recent publication available for each author or group of original, human, clinical reports about the technique were included. DATA EXTRACTION: The techniques and results for control of vertigo and hearing loss were compared. CONCLUSIONS: At least 11 articles have been published that indicate that intratympanic gentamicin treatments control vertigo well and provide acceptable rates of hearing loss. Intratympanic gentamicin should be the initial treatment of choice for unilateral disabling Meniere's disease that has failed medical therapy. The use of intratympanic steroids should remain investigational until more favorable data are available.

Anti-Bacterial Agents↗
PubMed1997

A study of the performance of patients with frontal lobe lesions in a financial planning task.

It has long been argued that patients with lesions in the prefrontal cortex have difficulties in decision making and problem solving in real-world, ill-structured situations, particularly problem types involving planning and look-ahead components. Recently, several researchers have questioned our ability to capture and characterize these deficits adequately using just the standard neuropsychological test batteries, and have called for tests that reflect real-world task requirements more accurately. We present data from 10 patients with focal lesions to the prefrontal cortex and 10 normal control subjects engaged in a real-world financial planning task. We also introduce a theoretical framework and methodology developed in the cognitive science literature for quantifying and analysing the complex data generated by problem-solving tasks. Our findings indicate that patient performance is impoverished at a global level but not at the local level. Patients have difficulty in organizing and structuring their problem space. Once they begin problem solving, they have difficulty in allocating adequate effort to each problem-solving phase. Patients also have difficulty dealing with the fact that there are no right or wrong answers nor official termination points in real-world planning problems. They also find it problematic to generate their own feedback. They invariably terminate the session before the details are fleshed out and all the goals satisfied. Finally, patients do not take full advantage of the fact that constraints on real-world problems are negotiable. However, it is not necessary to postulate a 'planning' deficit. It is possible to understand the patients' difficulties in real world planning tasks in terms of the following four accepted deficits: inadequate access to 'structured event complexes', difficulty in generalizing from particulars, failure to shift between 'mental sets', and poor judgment regarding adequacy and completeness of a plan.

Brain Diseases↗
PubMed2005

Improving efficiency of a small forensic DNA laboratory: validation of robotic assays and evaluation of microcapillary array device.

AIM: To present validation studies performed for the implementation of existing and new technologies to increase the efficiency in the forensic DNA Section of the Palm Beach County Sheriff's Office (PBSO) Crime Laboratory. METHODS: Using federally funded grants, internal support, and an external Process Mapping Team, the PBSO collaborated with forensic vendors, universities, and other forensic laboratories to enhance DNA testing procedures, including validation of the DNA IQ magnetic bead extraction system, robotic DNA extraction using the BioMek2000, the ABI7000 Sequence Detection System, and is currently evaluating a micro Capillary Array Electrophoresis device. RESULTS: The PBSO successfully validated and implemented both manual and automated Promega DNA IQ magnetic bead extractions system, which have increased DNA profile results from samples with low DNA template concentrations. The Beckman BioMek2000 DNA robotic workstation has been validated for blood, tissue, bone, hair, epithelial cells (touch evidence), and mixed stains such as semen. There has been a dramatic increase in the number of samples tested per case since implementation of the robotic extraction protocols. The validation of the ABI7000 real-time quantitative polymerase chain reaction (qPCR) technology and the single multiplex short tandem repeat (STR) PowerPlex16 BIO amplification system has provided both a time and a financial benefit. In addition, the qPCR system allows more accurate DNA concentration data and the PowerPlex 16 BIO multiplex generates DNA profiles data in half the time when compared to PowerPlex1.1 and PowerPlex2.1 STR systems. The PBSO's future efficiency requirements are being addressed through collaboration with the University of California at Berkeley and the Virginia Division of Forensic Science to validate microcapillary array electrophoresis instrumentation. Initial data demonstrated the electrophoresis of 96 samples in less than twenty minutes. CONCLUSION: The PBSO demonstrated, through the validation of more efficient extraction and quantification technology, an increase in the number of evidence samples tested using robotic/DNA IQ magnetic bead DNA extraction, a decrease in the number of negative samples amplified due to qPCR and implementation of a single multiplex amplification system. In addition, initial studies show the microcapillary array electrophoresis device (microCAE) evaluation results provide greater sensitivity and faster STR analysis output than current platforms.

California↗
PubMed2005

Effects of a medication assistance program on health outcomes in patients with type 2 diabetes mellitus.

PURPOSE: The effects of a clinic-based medication assistance program (MAP) on the health outcomes and medication use of patients with type 2 diabetes mellitus were studied. METHODS: In this retrospective analysis, data from the University of Arkansas for Medical Sciences pharmacy-managed MAP and outpatient pharmacy databases were collected for adult patients with type 2 diabetes mellitus who were monitored in the university's internal medicine clinic one year before and after enrollment in the MAP. Data on patient demographics, medication use, and disease indicators (glycosylated hemoglobin [HbA(1c)], high-density-lipoprotein [HDL] cholesterol, low-density-lipoprotein [LDL] cholesterol, total cholesterol, triglyceride, and blood pressure levels) were collected for the year before enrollment and for one year after enrollment. Statistical analyses were conducted using descriptive analyses, paired t tests, and the Wilcoxon signed rank test. RESULTS: Of the 401 patients enrolled in the internal medicine clinic who were enrolled in the MAP, sufficient data were available for 52 patients, of whom 73% were women, 50% were African American, and 48% were white. Their mean age was 59 years. All were self-paying customers, with 67.3% receiving Medicare benefits. Patients received more prescription medications (p < 0.001) and antihyperglycemic medications (p = 0.001) after enrollment in the program. Mean HbA(1c) and LDL cholesterol levels decreased significantly after enrollment (p < 0.001 for both). Mean HDL cholesterol levels and systolic and diastolic blood pressure measurements did not change significantly. CONCLUSION: A clinic-based MAP managing the use of pharmaceutical manufacturers' drug assistance programs increased indigent patients' access to antihyperglycemic medications and improved patients' clinical outcomes.

Adult↗
PubMed2001

[On the educational benefits of biological sciences in space].

Experimental results in Space Sciences are getting accumulated. It may be advisable for the educational activities of our society that we inform young people, not only of each experimental result, but also of a variety of novel views of life and the world introduced by the researches in Biological Sciences in Space. We are going to provide a data-base including elementary words and concepts in these fields.

Biological Science Disciplines↗
PubMed2001

Beta-blockers in congestive heart failure. A Bayesian meta-analysis.

PURPOSE: Congestive heart failure is an important cause of patient morbidity and mortality. Although several randomized clinical trials have compared beta-blockers with placebo for treatment of congestive heart failure, a meta-analysis quantifying the effect on mortality and morbidity has not been performed recently. DATA SOURCES: The MEDLINE, Cochrane, and Web of Science electronic databases were searched from 1966 to July 2000. References were also identified from bibliographies of pertinent articles. STUDY SELECTION: All randomized clinical trials of beta-blockers versus placebo in chronic stable congestive heart failure were included. DATA EXTRACTION: A specified protocol was followed to extract data on patient characteristics, beta-blocker used, overall mortality, hospitalizations for congestive heart failure, and study quality. DATA SYNTHESIS: A hierarchical random-effects model was used to synthesize the results. A total of 22 trials involving 10 135 patients were identified. There were 624 deaths among 4862 patients randomly assigned to placebo and 444 deaths among 5273 patients assigned to beta-blocker therapy. In these groups, 754 and 540 patients, respectively, required hospitalization for congestive heart failure. The probability that beta-blocker therapy reduced total mortality and hospitalizations for congestive heart failure was almost 100%. The best estimates of these advantages are 3.8 lives saved and 4 fewer hospitalizations per 100 patients treated in the first year after therapy. The probability that these benefits are clinically significant (>2 lives saved or >2 fewer hospitalizations per 100 patients treated) is 99%. Both selective and nonselective agents produced these salutary effects. The results are robust to any reasonable publication bias. CONCLUSIONS: beta-Blocker therapy is associated with clinically meaningful reductions in mortality and morbidity in patients with stable congestive heart failure and should be routinely offered to all patients similar to those included in trials.

Adrenergic beta-Antagonists↗
PubMed1982

Moving the collections of an academic health sciences library.

Expansion of the physical facilities of the Health Sciences Library at the University of North Carolina at Chapel Hill necessitated relocating the entire journal and book collections within the library. This paper discusses the problems involved in planning such a move, the gathering and analysis of relevant data, the formulation of an overall plan based on the data analysis, and the actual move. The use of specially-written computer programs greatly aided in the move's planning and execution and also yielded quantitative data describing the characteristics of an academic health sciences collection.

Academic Medical Centers↗
PubMed1980

Concept and implementation of a program for treatments and statistical or logical interrogations of a file: LOGIST.

LOGIST is a general program which can be used for the usual statistical interrogations and also for other basic operations such as a validity check, the transcoding and the listing of data essential to biomedicine and the human sciences. The objectives laid down for this program have enabled almost total transferability (using FORTRAN IV exclusively), simplicity in the interrogation language, clear presentation of results, reduction to a minimum of computer running time and working storage required and the facility for modification of program or addition of new sub-programs. All the possible statistical procedures have not been included yet but any such additions are quite simple. This program, despite its considerable size, can be satisfactorily used on a mini-computer. At present, it is installed on a Mitra 15 computer with a total memory capacity of 32 K words of 16 bits. Use with larger more powerful machines will increase its potential. Routine application to diverse problems (quality control of a file, transcoding, linking of data, etc....) is very satisfactory.

Computers↗